CAB Improve Medical +380(44)355-50-30

  • Director's Greeting

    Welcome to our sight IMPROVE MEDICAL LLC – authority, which has been accredited in Ukraine to assess compliance of products with the Regulations concerning medical products!

    Cоnfirming its European choice, Ukraine harmonizes its legislation and regulations step by step according to the European rules. As it is known since the 1st of July 2015 the Regulations for the medical products in Ukraine are acting and from the 1st of July 2017 Ukraine completely passed to the standard of  confirmation of the quality and safety of the medical products.

    IMPROVE MEDICAL LLC strongly maintains the European way of development in Ukraine and welcomes the steps to which our country adheres to. From our part we guarantee to work on the level of the European standards and principles: publicly, open-mindedly and in strict adherence to the letter of the Law.

  • Advantages of cooperation with CAB Improve Medical

    Save time and money by using our wide connections with Notified Bodies and Conformity Assessment Bodies.

    Accelerate introduction of your products to the market taking advantage of our ability to promptly conduct the necessary tests or service testing

    Increase value of your products through the mark of Improve Medical – one of the most reliable Ukrainian brands in the field of conformity assessment of medical devices with Technical Regulations and certification of quality systems in the field

    Be aware of all official industry innovations through our tried and tested system of informing the clients about the new regulatory requirements.

  • How we work?

    Personnel of the IMPROVE MEDICAL LLC sticks to its work by the following basic principles:

    Responsibility. We are scrupulous about our work and guarantee proper results.

    Competence.  High qualification and experience of the personnel guarantees the reliability of the results of our work.

    Partnership. Our employees shall answer your questions readily, pertaining both to conformity assessment procedure, and the certification of QMS.

CONTACT US
Background

Our Services

Conformity assessment body

Dialog concept by Artefact_wired

The IMPROVE MEDICAL LLC is an accredited authority concerning the assessment of the compliance of the medical products with the following Regulations:
— № 753 «Medical products»;
— № 754 «Medical products for the diagnostics in vitro»;
— № 755 «Аctive medical products for the implantation».

Testing laboratory

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Our medical device testing services help you solve non-routine, unusual, and highly complex problems.  Avomeen is FDA, GLP, and cGMP compliant, DEA-Licensed (class I-V), and ISO 17025-Accredited.

Information services

Dialog concept by Artefact_wired

Specialists of the IMPROVE MEDICAL shall explain peculiarities of the acting legislation and the practicalities of the use of them.  Addressing to our Center the manufacturers and suppliers of the medical equipment can always rely on obtaining exhaustive advices on the following questions:
 – Key aspects of the implementation and use of the Regulations for the specific medical devices. Peculiarities and choice of the procedure of the assessment of its compliance with the Regulations.
–  Requirements
to the marking of the medical devices.
–  Explanations concerning use of norms of the acting Ukrainian legislation regarding turnover of the medical devices.

Background

Our team

Tetiana Pazerska
Managing director
Oleh Us
Lead auditor
Tetiana Kolesnik
Project manager
Olena Hoi
Lead Auditor
Svetlana Zgonnyk
Head of Conformity Assessment Department
Maria Slabinska
Laboratory chief
Valentin Dembitsky
Test Lab Engineer

News

Webinar : “Procedures for conformity assessment with technical regulations on medical products in Ukraine”.
February 18, 2018

Dear colleague, Since July 1 st , 2017 all suppliers of medical devices in Ukraine have been obliged to follow radically new procedures for conformity assessment with technical regulations on medical devices. Have you been already provided…

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IMPROVE MEDICAL about ID marking of notification body in Ukraine
February 12, 2018

Article 29 of the Law of Ukraine “On Technical Regulations and Conformity Assessment”, in particular, stipulates that: in the cases specified in…

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IMPROVE MEDICAL about the importance of post-marketing supervision of medical products
February 6, 2018

The day before holding our educational event, topical webinar, dedicated issues post-marketing supervision of medical products and relevant issues introduction of…

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Improve Medical enters into agreements on recognition of medicinal products conformity assessment results with the largest Notified Bodies in Europe
January 22, 2018

The designated Conformity Assessment Body of Improve Medical has concluded agreements on recognition of conformity assessment results already with nine largest…

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Improve Medical: We take into account that some technical documents of the manufacturer of medical products is confidential.
September 17, 2017

The conformity assessment body in Ukraine – Improve Medical – continues to explain to the suppliers various current issues of legalization…

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Improve Medical: Seal of conformity agencies on declaration of conformity of medical products is not required
August 23, 2017

Tatyana Pazerskaya, a specialist with 19 years of experience, Director and Chief Auditor of Improve Medical, the conformity assessment body in…

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Peculiarities of regulation of Medical devices with ancillary medicinal substances in Ukraine.
April 12, 2017

It is difficult to imagine the modern health protection system  without medical devices and medicines. It is impossible to perform different…

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